A Study of Dementia and Neurological Problems in HIV Infected Patients Who Are Participating in ACTG A5175

This study has been completed.

Sponsor:

AIDS Clinical Trials Group

ClinicalTrials.gov Identifier:

NCT00096824

First Posted: November 16, 2004

Last Update Posted: March 18, 2015

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Participants will undergo neurological examinations and neuropsychological assessments at entry to both steps of ACTG A5175 and before the administration of the new antiretroviral regimen, then every 24 weeks until they discontinue ACTG A5175. Physicians will make targeted diagnoses at each study visit.

Behavioral: Neurological assessment

All participants will undergo neurological examinations and neuropsychological assessments.

Detailed Description:

Both the central and peripheral nervous systems (CNS and PNS) are affected by HIV; however, the causes of neurotoxicity in HIV infected patients are unknown. Initial data indicate that as many as 40% of patients with HIV develop some form of dementia. Other common neurological problems observed in HIV patients are peripheral neuropathy and opportunistic infections of the CNS. Most antiretroviral drugs used in the treatment of HIV have poor penetration into the CNS, which may explain how HIV persists in the CNS and contributes to the prevalence of dementia and other neurological disorders in HIV infected patients. This study will examine the prevalence of dementia and other neurological disorders in participants in ACTG A5175, "Once-Daily PI/NNRTI Therapy Combinations for Treatment Naive, HIV Infected Patients in Resource-limited Conditions."

The study will last approximately 2.5 to 3 years. Participants will undergo neurological examinations and neuropsychological assessments at entry to both steps of ACTG A5175 and before the administration of the new antiretroviral regimen, then every 24 weeks until they discontinue ACTG A5175. Physicians will make targeted diagnoses at each study visit.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

All participants who enrolled in ACTG study 5175

Criteria

Inclusion Criteria:

HIV-1 infected

Prior antiretroviral therapy for less than 7 days any time prior to study entry

CD4 count less than 300 cells/mm3

Willing to use acceptable means of contraception

Plans to stay in the area for the duration of study participation

Willing to adhere to study follow-up schedule for ACTG A5175 and this study

Have not begun ACTG A5175 antiretroviral therapy, but planning to start therapy after enrolling in this study

Exclusion Criteria:

Any active severe psychiatric illness (e.g., schizophrenia, severe depression, severe bipolar affective disorder) that, in the opinion of the site investigator, may interfere with the study results

Current drug or alcohol abuse that, in the opinion of the site investigator, would interfere with study requirements

Serious illness or hospitalization that, in the opinion of the site investigator, may interfere with the study results

Any condition that, in the opinion of the site investigator, would interfere with study requirements

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096824